Advocating in the United States for the disease myalgic encephalomyelitis (ME) has reached a new challenge that threatens the very core of the recognition for the disease. While some advocacy organizations have diverged and taken the alarming path of partnering with the US Health and Human Services (HHS) in adopting, using and educating with the government constructed "systemic exertion intolerance disease" (SEID), which does not define a distinct disease - MEadvocacy remains focused on advocating for the specific acquired neuroimmune disease ME as defined by international ME experts. This blog covers the challenges ahead for patients who have ME as described in the International Consensus Criteria (ICC) getting proper care and treatments.  It also details what ME advocates can do to ensure that the distinct disease ME per ICC gets adopted by HHS.

THE IMPORTANCE OF CRITERIA

A 2014 study titled: A comparison of health status in patients meeting alternative definitions for chronic fatigue syndrome/myalgic encephalomyelitis out of Griffith University in Australia comparing the ME-ICC and CFS-Fukuda concluded:

“These preliminary findings suggest that the ICC identifies a distinct subgroup found within patients complying with the 1994 CDC definition, with more severe impairment to their physical and social functioning.”

The importance of focusing on research and treatments using a “distinct” group of patients cannot be overstated. Lack of understanding about ME has led to massive suffering and early deaths of many ME patients. A continuation of the same inadequate information will lead to the same poor outcomes.

The ICC selects a distinct group of patients while the ME/CFS-SEID criteria continue to select an overly broad group of patients many of whom suffer from other conditions or idiopathic fatigue.

USING WRONG CRITERIA HARMS

CONSEQUENCES OF ME/CFS-SEID USURPING ME-ICC

• Wrong diagnosis of all people with ME (pwME) with the vague condition ME/CFS-SEID
• No specific testing for proper diagnosis as described in the IC Primer will be ordered by doctors
• False focus on behavior modification treatments such as pacing, diet, increased fluids, sleep hygiene, instead of demanding proper FDA approved treatments
• Lack of progress and deterioration will be blamed on patients not changing their behavior enough
• Impediment of meaningful scientific progress for the disease ME because of the use of vague criteria for cohort selection in studies (studying a mixed cohort will result in false or confusing findings that can not be replicated in follow-up studies)
• Without proper diagnosis and appropriate treatments, pwME will continue to suffer in solitude and darkness with no hope of healing and a cure.

Criteria that ignore immune, neurological or cardiac issues are deadly.

IMMUNE DYSFUNCTION IGNORED LEADS TO: 

(not an exhaustive list)

1. NK Cell function testing not done
2. Co-morbid pathogens (including reactivated viruses) ignored and left untreated causing suffering and irreversible damage
3. Higher risk of cancer ignored
4. Doctor not prepared for opportunistic infections

NEUROLOGICAL INVOLVEMENT IGNORED LEADS TO: 

(not an exhaustive list)

1. Not looking for reduced brain regional gray and white matter volumes
2. Ignoring reduced blood flow & low blood volume affecting cognition
3. Treating sleep issues with sleep hygiene instead of understanding brain abnormalities
4. Ignoring neuroinflammation in the dorsal root ganglia

CARDIAC ISSUES IGNORED LEADS TO:

(not an exhaustive list)

1. No referral to a cardiologist to check for life-threatening issues recognized in ME
2. Not looking for a small heart with a small left ventricular chamber
3. Not looking for cardiac and left ventricular dysfunction
4. Not checking for arterial elastic dysfunction

BACKGROUND

In 2011 a highly respected international group of ME experts created the International Consensus Criteria (ICC) using the name myalgic encephalomyelitis. The main reason for the creation of the ICC was to improve on the previous experts’ criteria, the 2003 Canadian Consensus Criteria (CCC), and to distinguish those who suffer from the acquired neuroimmune disease ME as opposed to those who suffer from various fatigue conditions (CFS).

The 2015 IOM report “Beyond ME/CFS”, commissioned by HHS, redefined the disease (against the advisement of the medical, advocacy and patients community) using the same ME/CFS label used in the CCC but using a different set of diagnostic symptoms (SEID) that were based on data evaluation that has most ME data removed. At this time the term ME/CFS can ambiguously mean either CCC or SEID criteria.

Over the course of MEadvocacy’s time advocating for patients, the ICC has gained popularity with researchers. In addition, many patients have had success using the IC Primer to educate their physicians. The #PwME4ICC petition asking HHS to adopt the International Consensus Criteria (ICC) has received overwhelming support.

At this time, MEadvocacy wants to clarify that while other organizations have chosen to adopt the ME/CFS-SEID criteria (while falsely and deceptively labeling themselves as “ME”), we will continue to advocate for ME as defined by the ICC. We have updated our website information to better reflect our position that ME-ICC is needed for patients to get proper diagnosis and treatments.

RECOGNIZING DISEASE LABELS

There have been many names given to the different patient populations involved in the history of ME.

To improve clarity, MEadvocacy will use labels that associate names with their criteria.

Red = Fatigue narrative

Blue = Immunological/neurological disease

Purple = Combo of fatigue narrative and immunological/neurological disease

• ME/CFS-SEID (Systemic Exertion Intolerance Disease - Beyond ME/CFS IOM Report - 2015) Link
• ME-ICC (International Consensus Criteria - 2011) Link
• ME-Hyde (Dr. Byron Hyde - enteroviruses - 2007/updated 2016) Link
• CFS-Reeves (Empirical - 2005) Link   
• ME/CFS-CCC (Canadian Consensus Criteria - 2003) Link
• CFS-Fukuda (Fukuda - 1994) Link
• CFS-Oxford (UK criteria - 1991)  Link   
• CFS-Holmes (Original CFS description - 1988) Link
• ME-Ramsay (Ramsay case description - 1981) Link

DISEASE DESCRIPTIONS

ME - As described in the International Consensus Criteria - is a complex disease involving profound dysregulation of the central nervous system (CNS) and immune system, dysfunction of cellular energy metabolism and ion transport and cardiovascular abnormalities. It appears in the epidemic (50+ worldwide) and sporadic forms.

The underlying pathophysiology produces measurable abnormalities in physical and cognitive function and provides a basis for understanding the symptomatology.

An easy to follow questionnaire to guide patients and doctors to consider ME as a diagnosis can be found on MEadvocacy’s website in the resource files.

SEID (Systemic Exertion Intolerance Disease) as described in the IOM (NAM) report - Is a simple list of 5 subjective common symptoms with 3 core symptoms and a choice of another 1 of 2. A patient who has been sick at least six months and at least half of the time has a substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities and is accompanied by fatigue, post-exertional malaise, unrefreshing sleep and has cognitive impairment and/or orthostatic intolerance.

Details for the IOM can be found on the CDC website as well as in the Beyond ME/CFS Redefining an illness Report Guide for Clinicians.

MEadvocacy prepared a chart comparing ME-ICC to SEID which clearly shows that, while there are some overlapping symptoms, patients with ME require much more medical intervention than what is suggested in the ME/CFS-SEID clinician’s guide. Without proper medical intervention, those with ME will continue to suffer from the same lack of care seen for decades.

ME/CFS-SEID IS NOT ME

HHS ACTIVITIES FORCING UNTESTED SEID ON ME COMMUNITY

As the title of the IOM report “Beyond ME/CFS” stated, the goal was to get beyond ME and CFS. The outcome has certainly gone far beyond recognizing ME. While most use the term ME/CFS, the current trend toward using the new name Systemic Exertion Intolerance Disease (SEID) and criteria to replace ME is alarming.

Health agencies across the globe are conspiring to deny the existence of ME as experienced by ME patients and described by the experts. There is a concerted push to adopt the 2015 IOM untested criteria and it is deceptively being put into use under different labels including ME/CFS, ME and SEID.

Since the IOM was rolled out in 2015, MEadvocacy has had concerns about the harm to ME patients if it was adopted. See our blog, Analysis of CFSAC August 2015 Recommendations for the IOM Criteria, outlining concerns posted in December 2015.

In Gabby Klein’s blog Exposing the Deception: SEID is not ME!, she discusses how SEID is being adopted by US government health agencies and many advocacy organizations.

In Feb 2019, the US Veterans Affairs posted in the Federal Register their intention to change the name to SEID/CFS:

“This updated revision also included changing the name of CFS to “Systemic Exertion Intolerance Disease (SEID)/Chronic Fatigue Syndrome (CFS).”

In October 2018, CDC’s department in charge of the US diagnostic codes (ICD-10-CM) put forth a proposal to do the following:

Change heading of G93.3 to:  “Postviral and related fatigue syndromes”

(Previously Postviral fatigue syndrome)

Move ME and CFS as well as add SEID

Final codes would be:

G93.30 - SEID, unspecified, NOS (Not otherwise specified)
G93.31 - Postviral fatigue syndrome

G93.32 - Myalgic encephalomyelitis

G93.33 - CFS / CFS NOS

G93.39 - Other postviral and related fatigue syndromes

Note:  This ADDS SEID to the medical codes. Many ME advocates expect this will lead to doctors changing ME patients’ diagnostic label from ME (G93.3) to SEID (G93.30).

MEadvocacy strongly objects to this proposal and submitted a 24 page document, created by advocate Jerrold Spinhirne, explaining in detail the reasons to reject this proposal.

Read MEadvocacy’s objections to this proposal to change the ICD codes in the following blogs:

• https://www.meadvocacy.org/seid_classification_usurping_me_must_be_stopped
• https://www.meadvocacy.org/deferral_needed_for_proper_icd_proposal_evaluation
• https://www.meadvocacy.org/meadvocacy_s_comments_rejecting_proposed_icd_10_cm_changes

A disturbing example of the mainstream view of ME/CFS-SEID can be seen in this 2017 article on MedPage Today where the diagnosis is SEID. From the article:

“No further testing is indicated in this patient who meets the clinical criteria for systemic exertion intolerance disease (SEID), previously termed chronic fatigue syndrome…. There is no specific objective laboratory test to diagnose SEID, and since the presenting symptoms are nonspecific, it remains a diagnosis of exclusion.”

ME/CFS-SEID in the eyes of mainstream medicine continues to ignore the realities of ME. This obfuscation is what has been killing us for decades.

Other countries should take heed to what is happening in the US because whatever path advocates and organizations choose here is going to have a worldwide impact as well.

GETTING DIAGNOSED

Because ME/CFS-SEID is a vague definition, patients who have ME-ICC will often fit the description for ME/CFS-SEID.  It is important to note that fatigue is not a requirement for an ME-ICC diagnosis.

ME-ICC is a distinct disease which should be ruled out BEFORE getting a CFS or ME/CFS-SEID diagnosis.  

CURRENT SITUATION

THE NARRATIVE FROM THE CDC

The CDC in July 2017 updated its website for CFS changing the description for diagnosis from the ‘Fukuda CFS’ diagnosis to the ME/CFS-SEID criteria and applied the label ME/CFS.

CDC’s Objective is to Erase ME Using the Following Actions:

• CFS-Fukuda will be retired and all doctors will be trained to diagnose patients with ME/CFS-SEID
• If the new US ICD-10 codes are adopted, doctors will use the G93.30 code and the label SEID
  
• Ongoing requests from the ME community and CFSAC for the CDC to adopt expert criteria (CCC and/or ICC) have continued to be ignored
  
• Nowhere on the CDC website is ME-ICC described properly (it is shown as a “historical’ criteria only). This means doctors are and remain unfamiliar with and do NOT know how to diagnose ME-ICC  
• A search on the CDC website for myalgic encephalomyelitis leads to the ME/CFS description with no clarification that ME is not the same as ME/CFS-SEID
  
  

THE NIH APPROACH TO ME-ICC

The NIH does not have a specific line item for ME-ICC in the list of diseases they research.  It continues to conflate CFS and ME/CFS-SEID with ME-ICC which leaves ME-ICC patients out in the cold when it comes to research. Current studies taking place at the NIH ME/CFS Research Consortia are using various non-ME criteria - including the clinical SEID definition which was only meant to be used for clinical purposes!

MOVING INTO THE FUTURE

STEPS NEEDED FOR RECOGNITION OF ME-ICC

• ME advocates and organizations need to be totally transparent whether they advocate for the distinct disease ME defined by our experts or HHS’  broad ME/CFS-SEID definition
• The labels used by organizations should reflect the disease criteria they opt to advocate for - if using the label myalgic encephalomyelitis, no promotion, education nor advocating for ME/CFS-SEID should take place
• CDC revises web page(s) to educate about ME-ICC
• CDC/NCHS differentiates ME from the non-disease CFS/SEID in their disease classification which will enable the tracking of how many patients have ME-ICC
• NIH conducts studies using the ICC criteria exclusively for cohort selection. This will speed up meaningful scientific findings for ME patients
• Medicaid, Medicare and insurance companies provide therapies and care plans for all levels of ME severity including in-home care similar to palliative and hospice care patients
• Social Security and other disability agencies recognize the severity of ME
• Prestigious doctor and medical associations educate and promote evaluation of ME-ICC for patients that have been previously diagnosed with CFS,  ME/CFS-SEID, fibromyalgia, chronic Lyme disease, POTS, gulf war syndrome and/or adrenal fatigue without the need to wait six months (CFS and SEID require 6 month wait)
  
• Doctors recognize some ME patients are too ill to safely visit their office and prescribe home medical services
  
• Doctors perform testing to rule out other diseases and tests that lead to quality of life improvement as found in the IC Primer
• Doctors are knowledgeable about the disabling aspect of ME and support disability claims
• Doctors advocate on behalf of patients for in-home care to be covered by insurance
• NIH initiates an in-house study for patients who fit the ME-ICC

WHAT YOU CAN DO

1. Insist HHS form an advisory committee specifically for ME-ICC
2. Insist the CDC revise their website reflecting to ME-ICC including medical information for doctors linking back to the IC Primer
3. Insist the CDC website states all patients be screened for ME-ICC 
4. Insist CDC/NCHS track the prevalence of ME-ICC
5. Insist NIH create a line item for research devoted to ME-ICC patients
   
6. Join more than 5,660 people and sign the #PwME4ICC petition to Demand US Health Agencies Recognize Myalgic Encephalomyelitis as Defined by ICC
7. VISIT OUR UPDATED WEBSITE
   
   We have updated our website to better serve the ME-ICC patients and to reflect the changes that have taken place in the ME community since the inception of our organization.
   
   Please drop by and learn more about our organization.  www.MEadvocacy.org.